More Than a Game of Keep Away

The PDRP takes effect in July. The AMA explains how individual doctors can keep their prescribing habits safe from reps, and how pharma can keep using the anonymous data—if the industry polices itself.

FOR Well Over A Decade, Pharmaceutical Representatives have had access to detailed information about the prescribing habits of the individual physicians they call upon. During that time, some physicians have protested—sometimes quite vehemently—that reps know too much about what they prescribe. State legislators have been listening. They have introduced a number of bills to keep all prescribing data away from salespeople—and sometimes away from whole companies. Now the American Medical Association (AMA) is seeking a compromise. On July 1, the AMA will introduce new procedures to give physicians some control over who sees information about the type and number of prescriptions they write. The Prescribing Data Restriction Program (PDRP) will take data away from reps and their direct supervisors, but leave it available to the company for marketing, compensation, and research. The rules allow the industry to retain access to prescribing data for most purposes, but they require companies to police their own sales forces. If they succeed, legislators will turn their attention elsewhere, and the industry can hang onto one of its most valuable data sources.

By enrolling in PDRP, individual physicians in the United States can prevent sales representatives and other pharma employees who contact them from accessing information about their prescribing practices. The goal of the program is to strike a reasonable balance between the interests of those physicians who object to sales representatives knowing individual doctors' prescribing history and the interests of many other stakeholders (pharmaceutical companies, public health agencies, academia, and consumers) who benefit from insight into physicians' prescribing decisions.

For this to work, major players must regulate themselves, especially pharmaceutical companies and Healthcare Information Organizations. (HIOs are companies that acquire, aggregate, analyze, and resell prescription data and other medical information.) If the industry cannot police itself effectively, state legislatures are likely to pass laws banning reps' access to prescriber data. Legislation has been introduced in several states this year, but the prospect of the PDRP program has stalled most of the bills. Only effective self-regulation can keep such laws off the books.

The Crux of the Issue

Tracking physicians' prescribing behavior for marketing purposes is hardly new. Enterprising detail men were gathering data bit by bit from doctors and pharmacists in the 1940s, and some successful reps maintained such informal data sources in their territories over the course of years and decades. As database technology became more sophisticated and affordable, HIOs created systematic, nationwide directories that picture any given doctor's prescribing habits, broken down by product and volume of prescriptions. Such databases have been available for license since 1993.

From the beginning, HIOs have recognized the privacy rights of patients. They have always taken pains to work only with de-identified patient data. An individual prescription discloses little about the physician who wrote it, and from a legal perspective, does not constitute personal information about the prescriber.

While laws protecting personal health information of patients are constitutionally founded in principles of privacy, business or professional information has not received similar protection under federal and state court decisions in the United States. Thus, experts in US privacy law assert that collecting, releasing, and using a physician's prescribing information has been—and remains—perfectly legal. Denying the public access to professional information could set a dangerous precedent and hinder informed decisions about healthcare providers.

But such legalities do not comfort physicians who feel they have a right to keep their prescribing information private. Nor has a legal explanation appeased doctors who argue that sales representatives inappropriately pressure them to write a drug. Although physicians have not made many formal complaints to the AMA—at least compared with the millions of sales calls made each month—physicians complain bitterly about sales representatives who wave data in their faces and point to discrepancies between what they said and what they wrote. Imagine the challenge to a physician's professionalism when he or she is told, "You promised me last month that you would write more of my product, but based on your prescription volume I can see that you haven't. Why is that?"

The Genesis of the Program

The PDRP did not spring to life overnight. It evolved, with support from the industry and HIOs, from "Best Practice Guidelines for Use of Prescribing Data by Industry," published by AMA in 2001. The guidelines support the confidentiality agreements that pharmaceutical companies enter when they purchase data from HIOs. They encourage pharmaceutical companies to, among other things, "Keep prescribing data confidential and expressly prohibit disclosure of prescribing data by sales representatives to any other party."